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CryoCath Freezor Tachycardia Approval Includes Cryomapping Indication

This article was originally published in The Gray Sheet

Executive Summary

CryoCath says it will pursue an expanded indication for its Freezor cardiac cryoablation system to address epicardial posteroseptal accessory atrioventricular pathways

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Atrial fibrillation trials

CryoCath gains FDA go-ahead to commence Phase I, 30-patient, three-center AF study using Arctic Circler Linear, Freezor Xtra and Freezor Max catheters. The Freezor cardiac cryoablation system was approved via PMA for atrioventricular node reentry tachycardia in April (1"The Gray Sheet" April 28, 2003, p. 5)...

Atrial fibrillation trials

CryoCath gains FDA go-ahead to commence Phase I, 30-patient, three-center AF study using Arctic Circler Linear, Freezor Xtra and Freezor Max catheters. The Freezor cardiac cryoablation system was approved via PMA for atrioventricular node reentry tachycardia in April (1"The Gray Sheet" April 28, 2003, p. 5)...

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CryoCath voluntarily will replace certain obsolete 7 Fr cryotherapy catheters that have demonstrated a breakage rate of less than 0.5% in over 4,000 procedures to date, the company says

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